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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, X-Ray, Stationary
510(k) Number K945708
Device Name SII 360 MS
Applicant
Scott Imaging Intl., Inc.
3510 Cottage Hill Rd.
Mobile,  AL  36609
Applicant Contact MICHAEL W SCOTT
Correspondent
Scott Imaging Intl., Inc.
3510 Cottage Hill Rd.
Mobile,  AL  36609
Correspondent Contact MICHAEL W SCOTT
Regulation Number892.1680
Classification Product Code
KPR  
Date Received11/21/1994
Decision Date 12/14/1994
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Radiology
510k Review Panel Radiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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